Detection of high-risk HPV in urine of high- and low-risk populations in India
5581 Background: Infection with high-risk HPV is involved in 90%-100% of cervical cancers. HPV detection in cervical cells, used as a supporting test for Pap smear positive patients, are much more sensitive than cytology but less specific for ongoing cervical cancer. Cervical cancer is one of the most common female tumors in countries lacking a screening program such as India. In this study we investigate the feasibility of a urine-based HPV DNA test. Methods: Matching urine and cervical samples were collected from 270 high-risk subjects from STD clinics or district brothels in West Bengal, and 50 low-risk subjects with no known predisposition to disease recruited in Mumbai. The Xenomics HPV DNA test involves isolation of DNA from urine and specific PCR amplification of the HPV E1 region to detect the presence of high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. Results were compared to the hc2 high-risk HPV DNA Test (QIAGEN). Discordant samples were resolved by DNA sequencing. Results: Of 320 patients, 248 samples (77.5%) were concordant between the Xenomics and hc2 assays. Of the discordant samples reactive by Xenomics but nonreactive by hc2, 31/38 (81.6%) contained high-risk HPV by DNA sequencing. 10 out of 34 (29.4%) of samples detected by hc2 but not by Xenomics were shown to contain high-risk HPV. Using DNA sequencing as the gold standard, the Xenomics test false negative and false positive rates were 10/180 (5.6%) and 7/140 (5.0%), respectively. The hc2 assay had a false negative and false positive rate of 31/184 (16.8%) and 24/136 (17.6%), respectively. Conclusions: HPV DNA can be isolated from urine samples and detected with sensitivity and specificity equal to or better than current assays based on cervical scraping. [Table: see text]